Getting stuck is a normal part of a product developer's life, here are 9 ways to fix that!
What is Risk Management? Here is a beautiful presentation to help you understand what Risk Management in Medical Devices looks like in compliance with ISO 14971; the standard for the application of risk management to medical devices.
Risk Management is defined as the “systematic application of management policies, procedures and practices to the tasks of analyzing evaluating controlling, and monitoring risk” Basically, risk management means the right people doing the right activities at the right time to prevent harm.
An insufficient or incomplete design input specification (DIS) can lead to a host of problems and create a big mess. A design input specification is a design control requirement for medical devices seeking regulatory approval. According to the FDA, your DIS must be testable, measurable, unambiguous, and traceable. Ambiguity leads to poor design inputs. … Continue reading “Your Design Input Specification is important beyond regulatory compliance”
https://youtu.be/OS2unSk68KQ The Manufacturer and User Facility Device Experience, or MAUDE, database is a tool that I use to help discover potential hazards when developing design input specifications for medical devices. It's very useful and I highly recommend this resource. Here is a simple guide I made to get your search started. … Continue reading Video | FDA’s MAUDE database: A medical device expert’s insight
Creating your design input specification (DIS) should be the first stage of any product design process. It is a vital tool your Design Team will use as the framework for the design and development of your medical device, and to also comply with regulatory requirements. Wait! Just what is DIS? In the simplest terms, your… Continue reading How to turn User Needs into Design Specifications (with tables)
A design input specification (DIS) plays a critical role in any product design process. The product DIS contains all the characteristics of a device that are used as a basis for product design. The level of detail that your design inputs cover can be the deciding factor that makes or breaks a smooth run to… Continue reading KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs
Don’t drain the bog; change the thinking. Getting bogged down is common in busy startup Medtech companies and in bigger, well-established companies too. However, established companies usually spend much less time being bogged down than start-ups. Why? Because they have more experience being bogged down, so they have developed methods to steer clear of “the… Continue reading Don’t get Bogged: Proven Strategies for Startups to Maintain Productivity Levels
Getting stuck doesn’t make you a failure—it makes you human. Accept that you are stuck and look for clues to answer this question: How did you get here?
“Why me?” —you may think. Overwhelmed and stressed out, you feel like the odds are stacked against you. You may feel anger. You may feel scared. Worst of all, you feel some embarrassment. You are bogged down.